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  • EuroClonality/BIOMED-2 guid...
    LANGERAK, A. W; GROENEN, Pjta; DELFAU-LARUE, M.-H; DISS, T; EVANS, Pas; GAMEIRO, P; GARCIA SANZ, R; GONZALEZ, D; GRAND, D; HAKANSSON, A; HUMMEL, M; LIU, H; BRÜGGEMANN, M; LOMBARDIA, L; MACINTYRE, E. A; MILNER, B. J; MONTES-MORENO, S; SCHUURING, E; SPAARGAREN, M; HODGES, E; DONGEN, Jjm Van; BELDJORD, K; BELLAN, C; BONELLO, L; BOONE, E; CARTER, G. I; CATHERWOOD, M; DAVI, F

    Leukemia, 10/2012, Letnik: 26, Številka: 10
    Journal Article

    PCR-based immunoglobulin (Ig)/T-cell receptor (TCR) clonality testing in suspected lymphoproliferations has largely been standardized and has consequently become technically feasible in a routine diagnostic setting. Standardization of the pre-analytical and post-analytical phases is now essential to prevent misinterpretation and incorrect conclusions derived from clonality data. As clonality testing is not a quantitative assay, but rather concerns recognition of molecular patterns, guidelines for reliable interpretation and reporting are mandatory. Here, the EuroClonality (BIOMED-2) consortium summarizes important pre- and post-analytical aspects of clonality testing, provides guidelines for interpretation of clonality testing results, and presents a uniform way to report the results of the Ig/TCR assays. Starting from an immunobiological concept, two levels to report Ig/TCR profiles are discerned: the technical description of individual (multiplex) PCR reactions and the overall molecular conclusion for B and T cells. Collectively, the EuroClonality (BIOMED-2) guidelines and consensus reporting system should help to improve the general performance level of clonality assessment and interpretation, which will directly impact on routine clinical management (standardized best-practice) in patients with suspected lymphoproliferations.